JPH1085306A - Container for medical care - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a container for medical care to which a filling container for medicine can be simply and aseptically connected, which securely keeps the aseptic condition at the connected part and makes communication operation ready between the filling container for medicine and a container made of resin for a liquid medicine. SOLUTION: The container for medical care 1 is made of resin comprising plural chambers, at least a part of a separating part 4 between the chambers is formed by a peel-seal part or weakly sealed part which can be opened from the outside. The first chamber 2 contains a liquid medicine, at least the second chamber 3 has a connecting opening 7 which is aseptically connected to an opening 9 of a container for restoring a medicine to be mixed with the liquid medicine and an elastic member is installed to keep the connecting opening 7 of the second chamber 3 and the opening 9 of the restoring container liquid- tight.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container, and more particularly, to a medical container capable of easily and aseptically connecting a container filled with a drug to a resin container, particularly to a medical container. The present invention relates to a medical container for storing an infusion solution to be used, a dialysate used for a circulatory system, or an organ preservative such as a transplanted organ.

[0002]

2. Description of the Related Art Medical containers such as bags and containers for infusions, dialysis solutions, organ preservation solutions and the like used for infusion are generally resin containers. Some infusions are mixed with antibiotics or the like at the time of use and injected by infusion. Conventionally, a syringe is used for such mixing, and the lysate is placed in the vial containing the antibiotic via the syringe. The antibiotic and the lysis solution are mixed, and the mixture is drawn from the vial with a syringe. Then, the syringe is pierced through the outlet of the infusion container, and the mixed solution is filled in the infusion container. Recently, an infusion container and a vial have been proposed. Such an infusion container is provided with a connection port, and a vial is connected to the connection port with its rubber stopper opposed. A communication needle is provided between the connection port and the vial, and the communication needle pierces the rubber stopper during use, so that the inside of the vial and the inside of the infusion container can be aseptically communicated. These structures are derived from the fact that drugs such as antibiotics are unstable and cannot withstand storage when dissolved in an infusion, and that antibiotics and other drugs cannot be sterilized by high-pressure steam as in infusion. Recently, an infusion container called a double bag has been proposed.
The storage room for the amino acid agent and the storage room for the sugar are formed separately. A part or the whole of the separating strip portion or the separating wall between the chambers is formed as a peel seal portion or a weak sealing portion, and serves as a separating strip portion or a separating wall which can be opened from the outside when used. For this reason, such a double bag separates and accommodates amino acids and saccharides that react with each other during production and storage so that they can be easily mixed aseptically when used.

[0003]

However, conventional medical containers such as an infusion container or a peritoneal dialysis container provided with a medicine-filled container have the following problems. The conventional medical container requires a communication needle in the vial support capsule and the connection port, and the connection mechanism is extremely complicated, so that manufacturing is not easy. Aseptic connection of vials and the like is difficult. In a conventional medical container, an operation of piercing a communication needle is required for the operation, and coring contamination may occur from a rubber stopper in the piercing operation. In view of this, there has recently been provided one in which a second chamber utilizing a double bag is directly aseptically filled with a freeze-dried product (JP-A-5-3904, etc.). This is because the freeze-dried product container is devised,
Prevents freeze-dried material from sticking to the container wall and hindering dispensing. However, such medical containers do not completely eliminate the risk of contamination during the aseptic filling operation. Also, a method of dispensing a predetermined amount from a large amount of freeze-dried product into the second chamber using a measuring spoon can be considered, but in such a method, the cake of the freeze-dried product is not necessarily distributed while maintaining a uniform titer. Not necessarily. Therefore, the present invention can easily and aseptically connect a container for filling a medicine, and can surely maintain an aseptic state of a connection portion. It is an object of the present invention to provide a medical container that can be made into a medical container.

[0004]

SUMMARY OF THE INVENTION The present invention has a plurality of chambers, and at least a part of a separation strip between the chambers is formed by a peel seal or a weak seal which can be opened from the outside. A resin container, the first chamber contains a drug solution, and at least another second chamber is formed with a connection port, the connection port of the filling container of the drug mixed with the drug solution The opening is aseptically connected, by providing a medical container characterized by being provided with an elastic member for maintaining the connection port of the second chamber and the opening of the filling container in a liquid-tight manner, The above object has been achieved.

The above-mentioned resin container is a non-constant volume container having at least a flexible wall. The resin container is formed from a sheet or a film, directly blow-molded, or injection-molded. The resin material of the container is a general-purpose resin such as a polyolefin resin, a vinyl chloride resin, and a polyester resin, and particularly, a polyolefin resin, for example,
Linear low-density polyethylene, high-density polyethylene, polypropylene, ethylene-vinyl acetate copolymer and the like.
In the present invention, the chamber of the resin container may be only the second chamber in which the first chamber containing the chemical solution and the filling container are connected, but other chambers may be provided in the resin container. The isolation strip that separates the chambers has resin walls adhered to each other so as to block communication between the chambers. At least a part of the isolation strip portion is formed of a peel seal portion or a weak seal portion that enables communication between the chambers from the outside during use. The peel seal portion and the weak seal portion generally have the same function, and have a function of shutting off the space between the chambers during storage and being easily opened from the outside of the resin container during use. In general, the peel seal portion is formed by forming the inner layer of a resin container with a plurality of resin compositions having different melting points, controlling the strength of the heat-sealing seal between the inner layers according to the temperature conditions, and enabling peeling from the outside of the seal portion. It is. In general, a weak seal is one in which the strength of a heat-sealing seal is tightly controlled by a sealing temperature, a sealing time, and the like, so that the sealing portion can be opened from the outside. However, in production, in order to improve the yield as much as possible, it is desirable that the isolation strip is formed by including these resin conditions and sealing conditions. Since the separating strip has the above function, it is desirable that the separating strip be peeled off when the internal pressure of the container is increased in the range of 0.01 to 0.20 Kgf / cm ² .

The chemical solution contained in the first chamber of the resin container is generally an electrolyte solution. Examples thereof include Ringer's solution containing lactic acid, acetic acid, bicarbonate and the like, high calorie infusion containing sugar, amino acid, peptide, fat, etc., dialysate, organ preservation solution and the like.
The chemical may be a simple solution or dilution of the lyophilized drug, and the chemical may be simple sterile water. The chemical is subjected to autoclave sterilization after being housed in a resin container in a liquid-tight manner. A connection port for connecting to the opening of the filling container is formed in the second chamber of the resin container. If the connection port is a resin container formed from a resin sheet or a film, the connection port to be attached at the time of heat sealing may be an opening. If the resin container is a blow-molded product, the connection port may use the opening for blowing as the connection port. The connection port may be formed by opening a predetermined position on the flexible resin container wall, and this may be used as the connection port.

[0007] The filling container filled with the drug mixed with the above-mentioned drug solution is a container having transparency, high gas barrier properties and high water vapor barrier properties, and is preferably a container capable of sufficiently blocking ultraviolet rays and the like. is there. Therefore, the filling container may be made of glass such as a vial or resin. Recently,
2. Description of the Related Art A resin container has been used which has advantages such as being hardly damaged and light, and being easy to incinerate and dispose. The filling agent may be a lyophilized product in addition to powders and granules. Also,
Drugs are relatively unstable drugs such as antibiotics and anticancer drugs,
Examples include physiologically active substances, vitamins, and electrolyte agents such as bicarbonates. Most of these are aseptically adjusted. The opening of the filling container may be a filling port for the medicine, or may be a separately formed opening other than the filling port.

[0008] The connection port of the second chamber and the opening of the filling container are connected aseptically. Aseptically connected means that the openings, the second chamber and the connection port of the filling container are maintained in a sterile state in advance and the openings are connected in a sterile atmosphere. Therefore,
The maintenance of the aseptic condition of such a part is performed by aseptically assembling or heat sterilizing the opening of the filling container, the second chamber and the connection port, chemical sterilizing treatment with alcohol, formalin, ethylene oxide gas, etc., γ-ray, electron beam The irradiation is performed by a sterile treatment such as a sterilization treatment with irradiation of ultraviolet rays or the like. An elastic member is provided for maintaining the connection port of the second chamber and the opening of the filling container in a liquid-tight manner. The elastic members are sandwiched between the openings to press and urge the peripheral edges of the openings by their elastic force to make the openings liquid-tight. Examples of such an elastic member include rubber, thermoplastic elastomer, and the like, and particularly, silicone rubber and the like are preferable.

In the medical container constructed as described above, when the container is used, the first chamber of the resin container is pressed from the outside, and part or all of the isolation strip is opened by increasing the internal pressure. The first and second chambers are communicated. Thereby, a part of the drug solution in the first chamber is injected into the filling container to dissolve the drug. Then, after sufficiently dissolving the drug, the drug is administered to the patient via a drip hole provided in a resin container or a filling container. Such a medical container has the following advantages. In a conventional medical container, the inside of the resin container and the inside of the filling container are communicated by a communicating means such as a communication needle.However, in such an operation, the filling container is rotated so that it takes time and effort, and when mixing the drug solution and the drug, It also takes time. On the other hand, in the medical container according to the present invention, the communication operation can be easily performed, and the mixing of the drug solution and the drug can be easily performed because a thin communication needle is not used. In a conventional medical container, it is necessary to dispose the communication means between the resin container and the filling container in a sterilized manner. For this reason, there is a risk that manufacturing may be difficult, and the sterility of the communication means may not be sufficiently ensured. Also avoid contact with the outside during storage,
Since the sterility has to be maintained, the hermetically connected structure between the resin container and the filling container has been complicated. On the other hand, in the medical container according to the present invention, the opening and the connection port of the filling container have a very simple structure. That is, on the structure of such a medical container, the opening of the filling container and the connection port may be connected aseptically, and the connection portion is provided before connection, and is subjected to processing such as chemical sterilization, heat sterilization, and irradiation sterilization. It can be easily maintained and connected to each other aseptically. After the filling container is connected, the second chamber can be easily sterilized by irradiation with an electron beam or the like. Therefore, the sterility at the connection portion is sufficiently ensured. In addition, since the medicine in the filling container is not transferred and charged into the resin container, the freeze-dried product does not stick to the wall of the freeze-drying container as in the related art, and does not hinder the dispensing of the fixed amount. There is no need to worry about a uniform titer distribution as in the method of dispensing a predetermined amount from a large amount of freeze-dried product into a filling chamber using a measuring spoon.

[0010] The medical container according to the second aspect is intended to sufficiently maintain the liquid tightness by the elastic member at the connection portion. That is, in the medical container according to the second aspect, the filling container is supported by a holder, and the holder is attached to the connection port with the filling container pressed against an elastic member. The holder may cover and support the entire filling container, or may partially support the filling container, but presses the filling container toward the connection port when attached to the connection port of the second chamber, Thereby, the elastic member is attached to the periphery of the opening of the filling container and the connection port by pressing and biasing the periphery.

According to a third aspect of the present invention, in the medical container according to the second aspect, the pressing force of the holder in the medical container according to the second aspect is simply and sufficiently exerted to increase the liquid tightness between the opening of the filling container and the connection port. It is an object. That is, in the medical container according to the third aspect, the holder is made of resin, and the holder is provided with a rib for pressing and urging the filling container against the elastic member. The holder is made of resin, ribs projecting from the holder are formed, and the ribs are brought into contact with the filling container. The rib can press the filling container by elastic deformation of the resin.
For this reason, a pressing force can always be applied to the filling container, and a constant pressing force can be easily applied to the elastic member, and the liquid tightness at each opening is maintained.

A medical container according to a fourth aspect is intended to further exert a rib pressing function in the medical container according to the third aspect. That is, in the medical container according to the fourth aspect, the rib is a bending elastic rib abutted in a state of being inclined with respect to the pressing direction of the filling container. When the elastic ribs abut against the pressing direction of the filling container, the elastic ribs abut in a bent state, which leads to a sufficient generation of a pressing force.

[0013] The medical container according to the fifth aspect is intended to facilitate separation and incineration of the medical container when the filling container or the like according to the second aspect is made of glass. That is, the holder in the medical container according to claim 5 is detachable from the connection port. If the attachment between the holder and the connection port is made detachable, after use, the holder can be easily removed, and the filling container, which is a glass container, can be separated from the resin container, so that sorting and incineration becomes easy.

According to the present invention, in the method for manufacturing a medical container according to the first aspect of the present invention, the isolation strip is formed in the resin container, and then the chemical is stored in a first chamber of the resin container in a liquid-tight manner. Autoclaving the chemical solution together with the resin container, disposing the resin container and the filling container in a sterile atmosphere, removing an opening lid of the filling container, and aseptically connecting the opening to the connection port. The above object has been achieved by providing a method for producing a medical container. In the method of forming the isolation strip, the peel seal portion or the weak seal portion having the above-described peel strength is formed by appropriately selecting heat sealing conditions, such as a heat sealing temperature, a heat sealing time, and a heat sealing pressure. Can be. Further, a peel seal portion or the like can be formed in the inner layer of the resin container using resin components having different components. For example, a resin component having a high melting point and a resin component having a low melting point are blended to form a peel seal portion or a weak seal portion in which the heat sealing temperature is set between the low melting point and the high melting point and the peel strength is appropriately adjusted. be able to. The isolation strip can be formed by a conventionally well-known method. For example, in a resin container molded from a polyethylene sheet having specific properties,
Using a heat seal bar, the temperature of forming the seal area was set at 11
0 ° C to 125 ° C, pressing force 4kg / c
m ² for one second (Japanese Patent Laid-Open No.
8702). It is assumed that the isolation strip formed in this way is peeled at an inner pressure of the container of 10 to 100 g / cm ² . Further, the kneaded composition of linear polyethylene and polypropylene is used as the inner wall layer of the resin container, the peripheral seal forming temperature for forming the container is in the range of 150 to 170 ° C, and the area of the weak seal portion is 130 to 150 ° C. As a range, a method for manufacturing an infusion container having a plurality of chambers has also been proposed. In the present invention, such a conventional method is adopted for forming the isolation strip, and the peel strength of the isolation strip is determined when the internal pressure of the container is increased in the range of 0.01 to 0.20 Kgf / cm ^2. It is desirable to peel off. In such a range, there is no possibility that the inside of the container is opened when the filling container is attached, and the wall can be easily separated from the outside during use.

By autoclaving the chemical solution together with the resin container after the elastic member is attached, the second chamber and the elastic member in the resin container can be easily sterilized. The temperature of the autoclave sterilization treatment is 100 ° C to 150 ° C, particularly preferably 105 ° C to 140 ° C. If the sterilization temperature is lower than the above range, the sterilization process becomes longer and causes a problem in production. If the sterilization temperature exceeds the above range, the resin container may be deformed by heat. To be disposed in a sterile atmosphere means to be disposed in a sterile room or a clean room and placed in a sterile operation environment. In such a method for manufacturing a medical container, not only the drug solution but also the second chamber, the connection port, and the elastic member can be easily sterilized by the autoclave sterilization treatment, and can be easily carried into a sterile atmosphere. Then, the assembling by aseptic connection between the connection port and the opening can be easily performed only by carrying the aseptically filled filling container into the aseptic atmosphere.

According to a seventh aspect of the present invention, there is provided a method for manufacturing a medical container, comprising:
It is another object of the present invention to provide a method for manufacturing a medical container, wherein the second chamber and the connection port after the autoclave sterilization treatment are carried into an aseptic atmosphere in a state where the inside of the connection port is securely maintained aseptically. That is, in the method for manufacturing a medical container according to claim 7, after attaching the elastic member to the connection port of the second chamber, a sterile maintenance lid is attached to the connection port to maintain the second chamber liquid-tight. Then, the autoclave is sterilized, and the aseptic maintenance lid is removed from the connection port when connecting to the opening of the filling container. By providing the aseptic maintenance lid, the inside of the second chamber and the connection port can be almost completely sterilized before being carried into the aseptic atmosphere.

[0017] A method for manufacturing a medical container according to claim 8 is as follows.
In the method for manufacturing a medical container according to the seventh aspect, it is an object of the present invention to enhance the sterilization assurance of each connection portion before connection.
That is, the surface of the sterile maintenance lid and the opening lid of the filling container in the method for manufacturing a medical container according to claim 8 is subjected to at least one of chemical sterilization, heat sterilization, and irradiation sterilization. And What is chemical sterilization?
The sterilization of the connection portion is performed with a chemical sterilizing agent such as alcohol, formalin, or ethylene oxide gas.
The heat sterilization includes not only the above-described steam sterilization of an autoclave or the like, but also the heat-dry sterilization in which hot air or the like is applied to the connection portion. The irradiation sterilization treatment is a sterilization treatment using gamma rays, electron beams, ultraviolet rays, or the like.

According to a ninth aspect of the present invention, there is provided a method for manufacturing a medical container, comprising:
At the time of connection between the filling container and the connection port of the second chamber in the method for producing a medical container according to claim 6, since sterility in the second chamber and the connection port may not be completely guaranteed,
The purpose is to sufficiently assure such sterility. That is, after the connection between the opening of the filling container and the connection port in the method for producing a medical container according to claim 9, the connection portion or the second chamber is subjected to electron beam irradiation sterilization through the second chamber. Features. The irradiation sterilization treatment is irradiation sterilization using γ rays, electron beams, and ultraviolet rays. However, the following electron beam irradiation sterilization is desirable in view of the reliability of sterilization, its economy, and its adaptability to mass production. In electron beam irradiation sterilization, the permeability of the electron beam is mainly determined by the acceleration voltage,
In high-energy type is the highest 13000 g / m ^2, which is 13000μm a thickness of water (specific gravity 1g / m ^2). However, when the accelerating voltage device is increased in size, the X-ray shielding equipment becomes large, and the resin material may be deteriorated. For this reason, a low-energy type acceleration voltage device of 1 MeV or less, particularly a low-energy type of 500 KV or less is desirable.
200 g / m ^2, for about 800 g / m ² of low energy type is the limit, the thickness of the electron beam transmittance in the resin material 1600
μm, especially 800 μm, is the optimum limit. From this, electron beam sterilization has a predetermined accelerating voltage of less than 1 MeV, especially low energy type of 500 KV to 50 KV. It can be arranged compactly on the production line without the need for the shielding equipment. That is, the permeability of the electron beam at an acceleration voltage of 500 KV is about 800 g /
When it is less than m ² , in particular, sufficient permeability can be obtained in a thin resin portion of 800 μm or less.

Therefore, in the case of directly performing irradiation sterilization on the mouth of the filling container, or in the case of performing irradiation sterilization on the mouth through the container wall of the second chamber, the filling of the filling container is performed in consideration of the effect of the medicine in the filling container. The thickness of the container is much larger than the above range, especially 3 m
m and the thickness of the resin container wall is desirably less than the above range. In addition, in the disinfection of microorganisms, as described in JP-A-7-16286, a D value of about 0.2 Mrad (2 kGy) is measured with B. pumilus (spores) E-601 which is an indicator for radiation bacteria. Have. 1cm ²
Per, the bacteria usually 10 ⁰ order is attached, if sufficiently considering safety versa assumption that there is attached to the 10 ^two orders. Sterilization assurance level (SAL)
^{Indicates a} survival rate of 10 ^-6 %. Therefore, the electron beam irradiation device 50 in the present embodiment has a filling container or the second chamber of 6 × 0.2 Mr.
The amount of electricity and the conveyor speed are adjusted so that sterilization is performed at a rate of at least ad, preferably at least 8 × 0.2 Mrad. Such medical containers are reliably guaranteed for sterilization and can be put into mass production.

[0020]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the medical container according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a sectional view of a first embodiment of the medical container according to the present invention. FIG. 2 is a sectional view of the resin container in the medical container of the first embodiment at the time of manufacture. FIGS. 3A and 3B are cross-sectional views of the filling container in the medical container of the first embodiment during manufacturing. FIG.
FIG. 3 is a cross-sectional view of the medical container of the first embodiment during manufacture. FIG. 5 is a schematic view of an electron beam irradiation apparatus when the medical container of the first embodiment is subjected to electron beam irradiation sterilization.

As shown in FIGS. 1 to 5, the medical container 1 of the present embodiment has a plurality of chambers 2 and 3, and at least a part of the separating strip 4 between the chambers 2 and 3 is externally provided. A resin container 5 formed of a peelable seal portion or a weak seal portion that can be opened, a chemical solution 6 is accommodated in a first chamber 2, and a connection port 7 is formed in at least another second chamber 3. Connection port 7
The opening 10 of the filling container 9 for the medicine 8 mixed with the medicine 6
Are connected aseptically, and an elastic member (rubber sealing material) 11 for maintaining the connection port 7 of the second chamber 3 and the opening 10 of the filling container 9 in a liquid-tight manner is provided. The filling container 8 is supported by a holder 12, and the holder 12 is attached to the connection port 7 in a state where the filling container 9 is pressed against the rubber sealing material 11. The holder 12 is made of resin, and the holder 12 is provided with a rib 13 for urging the filling container 9 against the rubber seal material 11. The rib 13 is a bending elastic rib that is brought into contact with the filling container 8 while being inclined with respect to the pressing direction. Further, the holder 12 is detachable from the connection port 7.

The infusion container 1 of this embodiment will be described in more detail. The resin container 5 used for the medical container 1 is made of a stretch blow-molded product. The resin container 5 is formed in two colors by using a mixed composition of linear low-density polyethylene and polypropylene as an inner layer and an outer layer as the linear low-density polyethylene (not shown). The mixed composition is composed of linear low-density polyethylene (density: 0.935 g / cm ³ , MI: 1, melting point: 126 ° C.) and polypropylene (density: 0.900 g)
/ Cm ³ , MI: 0.7, melting point: 160 ° C.)
These were mixed at a ratio of 10. The resin container 5 of this embodiment has a body diameter of 70 mm, a capacity of 150 mL, and a wall thickness of about 200 μm. When the thickness of the container wall is 200 μm, complete irradiation sterilization through an electron beam irradiation device of simple equipment to be described below through the container wall can be performed, and the container can be easily mounted on a mass production line. Infusion port 1 in resin container 5
4 is formed, and the drip opening 14 is closed in a liquid-tight manner with a rubber stopper 15 through which a drip needle is pierced, and the rubber stopper 15 is stopped by a stop member 16 on a ring. Resin container 5
The resin container 5 has a first chamber 2 and a second chamber 3 formed with the separating strip 4 as a boundary. The isolation strip portion 4 is formed in a peel seal portion or a weak seal portion, and is peeled open when the first chamber 2 reaches 0.1 kgf / cm ² . The first chamber 2 is filled with a chemical solution 6, and the chemical solution 6 is subjected to an autoclave sterilization process together with the resin container 5. The drug solution 6 is a physiological saline for dissolving a drug which is a freeze-dried product described later, and the physiological saline is filled in the first chamber 2 through a sterilization filter.

As shown in FIGS. 1 and 2, a connection port 7 is formed in the resin container 5, and a cylindrical resin mounting member 17 is provided in the connection port 7. The mounting member 17 is the connection port 7
Is heat-fixed to the inner wall, and the space between the mounting member 17 and the connection port 7 is liquid-tight. Further, a rubber seal material 11 is disposed in the opening of the attachment member 17, and the rubber seal material 11 is an elastic cylinder having an inner jaw 19 at a lower portion. An inner jaw is formed at the opening of the mounting member 17, and a circumferential ridge 18 is formed at the inner jaw. Inner jaw 1 of rubber seal material 11 on circumferential ridge 18
9 is pressed, the mounting member 17 and the rubber seal material 1 are pressed.
1 is sufficiently sealed. A circumferential groove 20 is formed on the outer wall surface of the mounting member 17, and a locking protrusion 21 of the holder 12 described below is fitted into the groove 20.

The opening 10 of the filling container 9 has a rubber sealing material 11
Is inserted into the opening of the rubber seal material 11 while pressing the inner jaw 19. The filling container 9 is formed of a glass vial, and can sufficiently shield ultraviolet rays, electron beams, and the like. The filling container 9 is filled with the medicine 8, and the medicine 8 is a dry product obtained by freeze-drying the aseptically filled solution. The above-mentioned holder 12 is put on the filling container 9, and the holder 12 is made of a cap-shaped polyethylene resin molded product.
The proximal opening of the holder 12 is connected to the connection port 7 of the second chamber 3, and the above-described locking ridge 21 and a cut 22 for breaking are formed on the inner wall of the proximal opening. When the locking projection 21 of the holder is fitted into the groove 20 of the mounting member 17, the holder 12 is attached to the connection port 7, and the holder 12 is connected to the filling container 9 via the bending elastic rib 13. It is attached while pressing. Bending elastic ribs 13 are formed on the ceiling surface of the holder 12, and the bending elastic ribs 13 are formed in an inclined state. Therefore, when the filling container 9 is pressed vertically from the ceiling surface of the holder 12, the elastic rib 1
No. 3 exhibits bending resin elasticity. Further, the breaking notch 22 is broken by rotating the holder 12 and the connection port 7 relatively, and the holder 12 can be removed from the filling container 9 by separating the skirt portion. In addition, an integrally formed suspension hole 23 is formed on the top surface of the holder 12, so that the medical container 1 can be hung on a stand or the like during infusion.

Next, a method for manufacturing the medical container 1 will be described. In the method for manufacturing the medical container 1 according to the first embodiment, the isolation strips 4 are formed in the resin container 5 and then the resin container 5 is formed.
The liquid medicine 6 is contained in the first chamber 2 in a liquid-tight manner, the liquid medicine 6 is autoclaved together with the resin container 5, the resin container 5 and the filling container 9 are arranged in a sterile atmosphere, and the opening lid 25 of the filling container 9 is removed. The opening 10 is aseptically connected to the connection port 7. After the rubber seal material 11 is attached to the connection port 7 of the second chamber 3, a sterile maintenance lid 26 is attached to the connection port 7, the second chamber 3 is kept liquid-tight and autoclaved, and the opening 10 of the filling container 9 is opened. At the time of connection, the aseptic maintenance lid 26 is removed from the connection port 7.
The surfaces of the aseptic maintenance lid 26 and the opening lid 25 of the filling container 8 are subjected to at least one of chemical sterilization, heat sterilization, and irradiation sterilization. Opening 10 of filling container 8
After the connection with the connection port 7, the connection portion or the second chamber 3 is sterilized by electron beam irradiation through the second chamber 3.

The method for manufacturing the medical container 1 will be described in more detail. The resin container 5 is formed by stretch blow molding, and the receiving portion of the stretch blow metal fitting is formed as the drip port 14 at the time of such forming, and the outlet is set as the connection port 7. Form. The isolation strip 4 is formed on a predetermined body of the resin container 5. Isolation section 4
Is formed at a heat seal forming temperature of 130 ° C. for 12 seconds. Next, the attachment member 17 is attached to the connection port 7 by heat welding, and a sterile maintenance lid 26 made of rubber is attached to the opening of the attachment member 17 as shown in FIG. The drug solution 6 is filled from the drip port 14, and the rubber stopper 15 and the stopper 16 are attached to the drip port 14. Then, the chemical solution 6 is put together with the resin container 2 for 110
Autoclave at ℃.

On the other hand, as shown in FIG. 3, the filling container 9 is filled with the medicine 8 aseptically. Drug 8 as freeze-dried product
First, the solution of the medicine 8 is passed through the sterilization filter and filled through the opening 10. Next, the opening lid 25 is attached to the opening 10 in a half-plugged state, and the filling container 9 is placed in a dust-free freeze-drying apparatus. The drug solution in the filling container 9 is freeze-dried, and in a state of a freeze-dried product, stoppering of the opening lid 25 is completed.

After the filling of the drug solution 6 and the drug 8, the resin container 5 and the filling container 9 are carried into an aseptic atmosphere.
After the surfaces of the sterile maintenance lid 26 and the opening lid 25 in the second chamber 3 are subjected to electron beam irradiation sterilization described later, the resin container 5 and the filling container 9 are carried into a clean room in a sterile atmosphere. The aseptic maintenance lid 26 of the resin container 5 and the opening lid 25 of the filling container 9 are removed under aseptic conditions in the clean room. After removal, the opening 10 of the filling container 9 is inserted into the opening of the rubber sealing material 11 as shown in FIG. 4, and the opening 10 is brought into contact with the inner jaw 19 of the rubber sealing material 11. Next, the holder 12
Is placed on the filling container 9, and while the holder 12 is pressed, the locking ridge 21 of the holder 12 is attached to the groove 2 of the mounting member 17.
0 is fitted. Then, the following electron beam irradiation sterilization is performed in the second chamber 3.

As shown in FIG. 5, an electron beam irradiation device 50 is provided above a belt conveyor 51, and includes a machine frame 52, a window frame 53 formed in the machine frame 52, and a window foil 54 attached to the window frame 53. , An acceleration tube 55 covering the upper part of the window frame 53, and an electron beam generator 56 provided in a vacuum chamber in the acceleration tube 55. The electron beam generator 56 is connected to the grid 5
7, a gun frame 58, and a filament 59. The filament 59 is energized and heated to generate thermoelectrons. The thermoelectrons are accelerated between the filament 59 to which a predetermined voltage is applied and the grid 57, and the window foil 54
Irradiates the light onto the conveyor 51. Note that the machine casing 52 is shielded with lead to prevent external leakage of X-rays and the like generated secondary by irradiation with electron beams. Therefore, the irradiation electron dose can be adjusted by the speed of the conveyor 51 and the amount of current supplied to the filament 59, and the permeability of the electron beam can be adjusted by the acceleration voltage. Such a process achieves sufficient and easy assurance of sterility at the time of connection. After the connection, the electron beam irradiation sterilization can be performed in the second chamber 3 of the resin container 5.
By this irradiation sterilization, the inside of the second chamber 3 is sterilized, and the outer surface of the filling container 9 is almost completely sterilized.

Next, the operation of using the medical container 1 of the present embodiment will be described. In the medical container 1 of the present embodiment configured as described above, the first chamber 2 is pressed to release the isolation strip 4. After peeling and opening, the first chamber 2 and the second chamber 3 are communicated. First room 2
Is injected into the filling container 9, and the drug 8 is dissolved in the drug solution 6. The lysate is returned to the first chamber 2 and the medical container 1 is applied to a drip patient. After the application, the holder 12 and the resin container 5 are relatively twisted, and the skirt portion is separated from the resin container 5 by the break notch 22, and the holder 12 is removed from the resin container 5. Then, the glass filling container 9 is removed, and the medical container 1 is removed.
Can be incinerated while being separated from those made of glass. Therefore, since the connection between the resin container 5 and the filling container 9 in the medical container 1 has no communication means or the like, sufficient liquid-tightness is maintained with a simple seal structure, and there is anxiety about storage of the medical container 1. Does not occur. In addition, during manufacturing, sterilization at the connection portion can be performed by, for example, electron beam sterilization irradiation after the connection, in addition to aseptic assembling, so that sterilization assurance at the connection portion can be enhanced. Furthermore, since the so-called bottle is connected to the drug 8 of the freeze-dried product, accurate titer and dissolution volume can be protected, and only the freeze-dried product is simply dispensed into the second chamber with a spoon or the like. It is more accurate than in the case of equality, and the sterilization assurance at the connection part is significantly improved. Also in the mixing operation of the drug solution 6 and the drug 8, dissolution and mixing are not troublesome because a thin tube such as a communication means is not used as a communication path. In this case, since the so-called bottle 8 is connected to the freeze-dried drug 8, the accurate titer and dissolution volume can be protected, and only the freeze-dried product is simply dispensed and filled with a spoon or the like. It is more accurate than before, and the sterilization guarantee is sufficiently provided. In the above embodiment, a blow-molded product is used for the resin container 5, but the present invention is not limited to this, and it may be formed from a resin sheet, film, or the like.

[0031]

As described above, the medical container according to the present invention has a plurality of chambers, and at least a part of the separating strip between the chambers can be opened from the outside. Or a resin container formed by a weak seal portion, a chemical solution is stored in the first chamber, and a connection port is formed in at least another second chamber, and the connection port is mixed with the chemical solution. The opening of the filling container for the drug to be performed is aseptically connected, and the elastic member for maintaining the connection port of the second chamber and the opening of the filling container in a liquid-tight manner is provided. It can be easily and aseptically connected, and the aseptic condition of the connection portion can be reliably maintained, and the communication operation between the medicine filling container and the chemical liquid resin container can be simplified.

[Brief description of the drawings]

FIG. 1 is a sectional view of a first embodiment of a medical container according to the present invention.

FIG. 2 is a sectional view of the resin container in the medical container of the first embodiment at the time of manufacture.

FIGS. 3A and 3B are cross-sectional views of a filling container in the medical container of the first embodiment during manufacture.

FIG. 4 is a cross-sectional view of the medical container of the first embodiment at the time of manufacture.

FIG. 5 is a schematic diagram of an electron beam irradiation apparatus when the medical container of the first embodiment is subjected to electron beam sterilization.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical container 2 1st chamber 3 2nd chamber 4 Isolation strip part 5 Resin container 6 Chemical liquid 7 Connection port 8 Drug 9 Filling container 10 Filling container opening 11 Rubber seal material 12 Holder 13 Bending elastic rib

Claims (9)

[Claims] 1. A resin container having a plurality of chambers, wherein at least a part of a separation strip between the chambers is formed by a peel seal portion or a weak seal portion that can be opened from the outside, One chamber contains a drug solution, and at least another second chamber has a connection port formed therein. The connection port is aseptically connected to an opening of a filling container for a drug mixed with the drug solution. A medical container characterized by being provided with an elastic member for maintaining the connection port of the second chamber and the opening of the filling container in a liquid-tight manner. 2. The medical container according to claim 1, wherein the filling container is supported by a holder, and the holder is attached to the connection port with the filling container pressed against an elastic member. . 3. The medical container according to claim 2, wherein the holder is made of resin, and the holder is provided with a rib for urging the filling container against an elastic member. 4. The medical container according to claim 4, wherein the rib is a bending elastic rib abutted in a state inclined with respect to a pressing direction of the filling container. 5. The medical container according to claim 2, wherein the holder is detachable from the connection port. 6. The method for manufacturing a medical container according to claim 1, wherein the isolation strip is formed in the resin container, and then the chemical is stored in a first chamber of the resin container in a liquid-tight manner. The chemical solution is autoclaved together with the resin container, the resin container and the filling container are arranged in a sterile atmosphere, an opening lid of the filling container is removed, and the opening is aseptically connected to the connection port. Manufacturing method of medical container. 7. After the elastic member is attached to the connection port of the second chamber, an aseptic maintenance lid is attached to the connection port, the second chamber is kept liquid-tight, the autoclave is sterilized, and the filling container is filled. 7. The method for manufacturing a medical container according to claim 6, wherein said sterility maintaining lid is removed from said connection port when connecting with said opening. 8. The medical container according to claim 7, wherein the surfaces of the aseptic maintenance lid and the opening lid of the filling container are subjected to at least one of chemical sterilization, heat sterilization, and irradiation sterilization. Manufacturing method. 9. The medical treatment according to claim 6, wherein after the connection between the opening of the filling container and the connection port, the connection section or the second chamber is sterilized by electron beam irradiation through the second chamber. Method for manufacturing containers for packaging.